Martini-Klinik am UKE GmbH
Hamburg, 20246, Germany
NCT Number: NCT06273735
This prospective observational study investigates the incidence of acute myocardial injury after radical prostatectomy for prostate cancer. Consecutive patients undergoing elective open or robot-assisted radical prostatectomy at the Martini-Klinik are included. High-sensitivity cardiac troponin I (hs-cTnI) is measured preoperatively and on postoperative days 1 and 2 to identify acute myocardial injury, defined according to the 4th Universal Definition of Myocardial Infarction. Secondary outcomes include the incidence of myocardial infarction, major adverse cardiac and cerebrovascular events, and mortality during the hospital stay and at 24 months. Baseline patient characteristics (age, BMI, cardiovascular risk factors including the Revised Cardiac Risk Index, comorbidities, and prior cardiac therapy) as well as surgical and tumor-specific parameters are recorded. Associations between acute myocardial injury and clinical variables are analyzed.
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Notify Me18 year and older
Male
Observational
Hamburg, 20246, Germany
Primary endpoint:
Acute myocardial injury, defined as a postoperative troponin concentration above the 99th percentile sex-specific upper reference limit with a) an increase of ≥ 50% from baseline if the baseline troponin I or T concentration was below the 99th percentile sex-specific upper reference limit or with b) an increase of ≥ 20% from baseline if the baseline troponin I or T concentration was above the 99th percentile sex-specific upper reference limit. percentile or with b) an increase of ≥ 20 % compared to the initial value if the initial troponin I or T concentration was above the sex-specific upper reference limit of the 99th percentile.
Secondary endpoints:
Furthermore, the included patients are followed up for 24 months and questioned about cardiovascular events.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An intervention is carried out as part of the normal clinical procedure regardless of the study measurement parameters.
Time frame: the day before surgery until 24months follow-up
Survey of the rate of asymptomatic and symptomatic myocardial damage. A troponin determination is carried out before the prostatectomy as well as a troponin determination on the first and second postoperative day. An ACS is recorded clinically. Myocardial events and treatment of myocardial infarction are also recorded during the follow-up.
Martini-Klinik am UKE GmbH
Other
Evaluation of Intra- and Postoperative Cardiac Events in Patients With Localised Prostate Carcinoma and Radical Prostatectomy
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